MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN TIBIAL DRILL GUIDE SIZE 7; PLATE, FIXATION, BONE

Model Number	71434340
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, upon inspection in sterile processing of instruments, it was found that the sizer had separated from handle.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
Results of investigation: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the sizer is broken off.This device also has excessive wear/usage.The device was manufactured in 2009.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN TIBIAL DRILL GUIDE SIZE 7
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11376803
• Report Number: 1020279-2021-01569
• Device Sequence Number: 3847681
• Product Code: HRS
• UDI-Device Identifier: 03596010549907
• UDI-Public: 03596010549907
• Combination Product (Y/N): N
• Initial Reporter State: TN
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71434340
• Device Catalogue Number: 71434340
• Device Lot Number: 09EM02960
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1